Services

Doing the math really adds up.

TK/TD analyses and model-based development strategies are crucial steps in reaching your product’s full potential. Our models bring together information about exposure and response to predict safety outcomes. And that’s not all. TK/TD modeling can also help identify knowledge gaps and determine the lowest observable effect level (LOEL). So what are you waiting for?

Better understand the PBTK behind your compounds.

Simulations Plus offer physiologically based toxicokinetic (PBTK) modeling and simulation consulting services using GastroPlus™  –industry’s most sophisticated platform for the prediction of absorption and disposition in human and animal species.  GastroPlus, with its #1-ranked Advanced Compartmental Absorption and Transit (ACAT™) and PBTK models, has features and capabilities to support  compound development in all phases of discovery and registration.

If your organization does not have the time or resources to use our software directly, or if you need a fast turnaround on a particular project, our comprehensive consulting service is the solution. Our interdisciplinary team of experts can review your data, work with you to identify the issues of concern, and apply our technology and expertise to offer unique insights that will guide your projects towards an optimal strategy and outcome.

The combination of PBTK modeling techniques with our population TK/TD modeling and simulation expertise allows us to offer a variety of high-value end to end consulting services.

For example:

  • We can predict the steady state concentration of your compound in rats dosed daily.
  • We can predict the oral bioavailability of you compound using our ACAT™ model combined with predicted CYP kinetic parameters.

Other examples of the ways our PBTK modeling & simulation scientists can assist with your research include:

  • in silico screening of compound libraries based on PK endpoints (F%, Cmax, AUC)
  • extrapolation of in vitro metabolism and transport data to in vivo values (IVIVE) and predicting exposures in animals and humans
  • population toxicokinetic and toxicodynamic predictions for different age groups
  • conduct virtual bioequivalence (BE) trials to optimize study design
  • prediction of tissue concentrations

All major regulatory agencies around the world, including the U.S., Canada, Europe, China, and Japan have licenses to GastroPlus, with reviewers in all divisions trained on the program. Our reputation and credibility at regulatory agencies has led our clients to deploy GastroPlus as an integral component of compound evaluation prior to regulatory interactions and submissions.